MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR PROFESSIONAL MONITOR; PROTHROMBIN TIME TEST

Model Number 200431

Device Problems Poor Quality Image (1408); Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Investigation pending; waiting for product to be returned.

Event Description

A customer in (b)(6) reported a display issue with their inratio2 monitor.They reported a missing line in the part of the display showing the test result; the lower line of the first digit is missing.No actual date of occurrence was provided; no further details provided.

Manufacturer Narrative

The monitor associated with the complaint was returned for investigation.The customer reported that the inratio lcd display was missing a segment of the first inr digit.The customer's display issue was replicated during in-house investigation.After relieving pressure between the lcd screen and the pcb board, all digits appeared fully.Display issues can be attributed to the pressure of the attachment between the lcd screen and the monitor circuit board.The monitor met functional and thermistor testing requirements.Issues of missing segments on inratio 2 monitor display were investigated and as a result, a corrective action was initiated.This instrument was manufactured prior to the implementation of the corrective actions that were implemented.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL MONITOR
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5831828
• MDR Text Key: 51385700
• Report Number: 2027969-2016-00537
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1